Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients

Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study

The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.

Study Overview

• Status: Completed
• Conditions: Renal Transplant Recipients
• Intervention / Treatment: Drug: Tacrolimus sustained-release capsule

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Changchun, China
  • Chengdu, China
  • Guangzhou, China
  • Nanjing, China
  • Nanning, China
  • Shanghai, China
  • Shenyang, China
  • Wuhan, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years of age, male or female
• 1-5 years after kidney transplantation
• The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
• The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
• At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
• gingival hyperplasia and treatment requested by the patient
• polytrichia and interventional therapy requested by the patient
• post-transplantation hypertension
• post-transplantation hyperlipemia (total cholesterol>5.7 mmol/L (220 mg/dl))
• Serum creatinine<200 μmol/l ( 2.3 mg/dl)
• A promise is made to take contraceptive measures during the study (women at childbearing ages).

Exclusion Criteria:

• Patients having accepted transplantation of other organs apart from kidney transplantation
• Patients with 24-hour urine protein>2 g
• Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
• Patients with refractory infectious foci
• Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
• Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
• Patients allergic to tacrolimus or other basic medications
• Pregnant or lactating women
• Patients having participated in other clinical trials within the previous month
• Other patients who are considered by doctors unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus sustained-release capsule group; Oral	Drug: Tacrolimus sustained-release capsule; Oral; Other Names: FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in creatinine level	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in creatinine level		Baseline and Weeks 1, 2, 4, 8 and 12
Incidence of rejection reaction after drug use		Up to Week 24
Plasma concentrations of tacrolimus		Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in blood pressure	Diastolic pressure and systolic pressure	Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in blood lipid	Total cholesterol, high density lipoprotein, low density lipoprotein, triglyceride	Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in liver function	Aspartate aminotransferase, alanine aminotransferase, bilirubin	Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in fasting blood glucose		Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in gingival hyperplasia		Baseline and Week 24
Change from baseline in polytrichia		Baseline and Week 24
Safety assessed by Adverse Events		Up to 24 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma China, Inc.
• Investigators: Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimated): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: FK506; Renal transplant recipients; cyclosporin
• Additional Relevant MeSH Terms: Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: BJ309CT-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.